QC Deviation Specialist III

Astrix; Springfield (MO); Sur place; USD 61 992 - 64 747; Plein temps

Résumé du poste

A leading global CDMO is seeking an experienced QC Deviation Specialist III for an onsite contract in Springfield, MO. This role emphasizes leading complex deviation and Out-of-Specification investigations while ensuring compliance with GMP and regulatory standards. Candidates should have over 10 years of relevant experience and a strong background in Quality Systems Management. The position offers a pay rate of $45 to $47 per hour for a project-based contract lasting 3 to 6 months, potentially extending further.

Qualifications

• 10+ years of experience in Quality Systems Management.
• Experience in deviation and Out-of-Specification (OOS) investigations.
• Strong experience in RCA methodologies and CAPA.
• Proven expertise in a regulated manufacturing environment.

Responsabilités

• Lead and author Manufacturing and QC deviation investigations.
• Perform root cause analyses and define effective corrective actions.
• Execute Out-of-Specification investigations in alignment with GMP.
• Collaborate with Manufacturing, QC, and Quality Assurance teams.
• Review investigation data to identify trends and continuous improvement.

Connaissances

Quality Systems Management

Root Cause Analysis (RCA)

Corrective and Preventive Actions (CAPA)

Regulatory Compliance

Documentation Skills

Analytical Skills

Communication Skills

Formation

Bachelor’s degree in a scientific, engineering, or technical discipline

Outils

Electronic Quality Systems (TrackWise, Veeva Vault)

Description du poste

Pay Rate Low: 45 | Pay Rate High: 47

QC Deviation Specialist III (Contract)

Location: Onsite | Springfield, MO (Greene County)

Pay: $45–$47/hour

Terms: Project-Based Contract (3–6+ months, with potential extension)

Our client, a leading global CDMO, is seeking an experienced QC Deviation Specialist III to support a high-impact quality initiative at their Springfield, Missouri site. This is a project-based, onsite contract role focused on leading and executing complex deviation and OOS investigations across Manufacturing and Quality Control.

If you’re a seasoned quality professional who thrives in regulated environments, enjoys digging into root cause, and can confidently guide others through investigations — this role is built for you.

What You’ll Be Doing

• Lead and author Manufacturing and QC deviation investigations, ensuring thorough, compliant, and timely documentation
• Perform root cause analyses (RCA) and define effective corrective and preventive actions (CAPAs)
• Execute and draft Out-of-Specification (OOS) investigations in alignment with GMP and regulatory standards
• Partner closely with Manufacturing, QC, and Quality Assurance teams to support investigations and drive closure
• Provide coaching, mentoring, and guidance to investigators, including investigator qualification support
• Review investigation data to identify trends, recurring issues, and continuous improvement opportunities
• Support and strengthen the site’s Quality Management System (QMS)
• Ensure all work complies with GMP, ISO, and applicable regulatory requirements

What We’re Looking For

• 10+ years of experience in Quality Systems Management with direct involvement in deviation and OOS investigations
• Strong expertise in RCA methodologies and CAPA development and execution
• Proven experience authoring high-quality investigations in a regulated manufacturing environment (pharma, biotech, medical device, CDMO, etc.)
• Ability to work independently while collaborating cross-functionally
• Excellent analytical, documentation, and communication skills
• Bachelor’s degree in a scientific, engineering, or technical discipline preferred

Nice to Have

• Hands-on experience with GMP regulations and FDA / ICH guidance
• Experience with electronic quality systems (TrackWise, Veeva Vault, or similar)
• Prior experience training or mentoring investigators or quality staff